Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

Inclusion Criteria

• Hospitalized males or females 3 months to 17 years of age
• Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations
• Expected duration of treatment with antibiotics is a minimum of 3 days administered IV, for a total of 5 to 14 days administered IV or IV followed by PO
• If the subject is a female of child-bearing potential she must have a negative pregnancy test at the screening visit or be capable of practicing an adequate method of contraception, and agree to continue the same method for 1 month following the TOC visit. Lactating subjects are not to be included.
• Subjects may be enrolled upon a surgically (laparotomy, laparoscopy, or percutaneous drainage) confirmed cIAI revealing at least one of the following:
• Gross peritoneal inflammation with purulent exudate within the abdominal cavity
• Intra-abdominal abscess
• Macroscopic intestinal perforation with diffuse peritonitis OR
• Subjects may be enrolled on the basis of a suspected cIAI, which must be supported with radiological evidence (ultrasound, abdominal plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of gastrointestinal perforation or localized collections of potentially infected material and at least one of the following:
• Symptoms referable to the abdominal cavity (eg, anorexia, nausea, vomiting or pain)
• Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity
• Fever
• Leukocytosis
• The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) or percutaneous drainage.

Exclusion Criteria

• Presumed spontaneous bacterial peritonitis
• All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an cIAI secondary to pancreatitis
• Early acute or suppurative (nonperforated) appendicitis unless there is evidence of an abscess or peritoneal fluid containing pus and micro-organisms suggestive of regional contamination
• Infections originating from the female genital tract
• Known severe immunosuppression. Subjects with known mild immunosuppression (eg, Type I or II diabetes mellitus, trauma, or absolute neutrophil count [ANC] between 1000 and 1500 cells/mm3) may be enrolled.
• Congenital or documented acquired QT prolongation
• Receiving concomitant treatment with QT prolonging drugs
• History of tendon disease/disorder related to quinolone treatment
• Pathogenic organisms suspected or identified (eg, Pseudomonas) which are resistant to any of the study drugs
• Abnormal musculoskeletal findings at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease)
• History of myasthenia gravis